Effect of Hydroxychloroquine on Atrial Fibrillation Recurrence

NCT03592823 | Unknown Phase 4

• 1 other identifier: AF-1
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation is the most common arrhythmia in clinic. It can lead to heart failure or stroke, and has a high disability rate and mortality rate. At present, although radiofrequency ablation can cure atrial fibrillation, the success rate is only 50\~70%, and has a high recurrence rate. In recent decades, no effective new antiarrhythmic drugs have been introduced, but there are side effects in long-term application of the existing antiarrhythmic drugs. Therefore, it is urgent to provide new and effective antiarrhythmic drugs. Autophagy level of atrial myocytes in atrial fibrillation patients was significantly higher than that in sinus rhythm. Hydrochloroquine (HCQ) is a hydroxychloroquine sulfate composed of 4- amino quinoline compounds. As an effective inhibitor for autophagy, HCQ could effectively prevent the increased autophagy level of atrial myocytes in atrial fibrillation rabbits, prevent atrial effective refractory period (AERP) shortening, and decrease the rate and duration of atrial fibrillation. At present, hydroxychloroquine is mainly used in the treatment of rheumatic immune system diseases and anti malaria. Because of its good safety and small side effects, HCQ has become an indispensable member of drugs in the combined treatment of rheumatoid arthritis and systemic lupus erythematosus patients. In recent years, studies have reported that hydroxychloroquine plays an important role in the prevention and treatment of cardiovascular diseases. Chloroquine could effectively shorten the action potential of atrial myocytes by blocking the inward rectifier potassium ion channel (Kir2.1) and reducing the inward potassium ion current Ik1. HCQ could also reduce 72% (P=0.002), and 70% for the risk of coronary heart disease, stroke, and transient ischemic disease. So the investigators speculate that HCQ may be a potential drug to block the occurrence of acute atrial fibrillation.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Recurrence rate of atrial fibrillation after radiofrequency catheter ablation

  Recurrence rate of atrial fibrillation after radiofrequency catheter ablation

  up to 1 year

Secondary Outcomes (1)

• Side effects

  up to 1 year

Study Arms (2)

control

NO INTERVENTION

receiving radiofrequency ablation and anticoagulant therapy

hydrochloroquine

EXPERIMENTAL

receiving radiofrequency ablation, anticoagulant therapy and hydrochloroquine treatment (200 mg,bidpo)

Drug: Hydroxychloroquine Sulfate 200 Mg Tablet

Interventions

Hydroxychloroquine Sulfate 200 Mg Tablet DRUG

200 mg, bidpo.

hydrochloroquine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Successful radiofrequency ablation of atrial fibrillation within 24 hours

You may not qualify if:

• History of cerebrovascular disease: ischemic stroke, cerebral haemorrhage and transient ischemic attack.
• History of cardiovascular disease:unstable angina, myocardial infarction, coronary revascularization and congestive heart failure.
• History of renal impairment.
• History of Type I diabetes mellitus or Type II diabetes uncontrolled.
• History of liver impairment.
• History of alcoholism or drug abuse.
• Known severe skin rash or damage.
• Known retinal pigmentation and visual field defect.
• Allergy to any component of hydroxychloroquine.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

Electrocardiograph

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Yue Li, MD

CONTACT

86-451-85555673; ly99ly@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 19, 2018
• Study Start: August 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: August 1, 2020
• Last Updated: July 19, 2018

Record last verified: 2018-06

Locations

CN (1)